Polymer Exemption for New Chemicals under the Toxic Substances Control Act (TSCA)
It is the intention of the polymer exemption to encourage the manufacture of safer polymers by reducing industry's reporting burden for this category of chemical substances, and to concentrate the Agency's review resources on substances expected to pose higher risk.
Under the terms of the polymer exemption, manufacture and distribution of polymers meeting the exemption criteria can take place without submission of a PMN or an exemption notice prior to commencement of manufacture for a commercial purpose. There are recordkeeping requirements to document compliance with the exemption criteria, however, and manufacturers of exempted polymers are required to submit an annual report on the number of exempted polymers for which their manufacture or importation commenced under terms of the exemption during the preceding calendar year.
In 1995 the polymer exemption rule was amended to eliminate unnecessary EPA review of eligible (low risk) polymers, to transfer the burden of ensuring eligibility from EPA to the manufacturer, to encourage the manufacture of safer chemicals and substances produced with low exposure and low release, and to reduce the number of PMNs through exemption (34 percent of PMNs filed before the amendments would qualify for polymer exemption).
The exemption now relies on comprehensive recordkeeping for compliance purposes, adopts the international OECD (Organization for Economic Cooperation and Development) definition of "polymer" and amends the "two percent" reporting rule for polymers to allow greater flexibility for polymer manufacture.
The eligibility criteria are:
- Polymers with molecular weight (MW) of 1,000 daltons or greater and less than 10,000 daltons are eligible, with restrictions on low MW species and reactive functional groups;
- Polymers with MW of 10,000 daltons or greater, with restrictions on low MW species.
The changes made in 1995 have made the polymer exemption generally less restrictive: the list of allowable elements has been expanded to include chlorine, bromine, iodine as monatomic counterions; and fluorine, chlorine, bromine and iodine if covalently bound to carbon; biopolymers which meet the polymer definition are no longer excluded; polymers that are cationic or anticipated to become cationic in aquatic environments are now eligible for exemption if the polymer is solid, not soluble or dispersible in water and will be used only in solid phase, or equivalent weight is equal to or greater than 5,000; and there is an expanded list of specified reactants for polyesters.
Polymers which degrade, decompose, or depolymerize are ineligible for the exemption. Also ineligible are several classes of polymers:
- polymers that are prepared from monomers or other reactants that are not on the TSCA (Toxic Substances Control Act) Inventory are ineligible,
- as are water-absorbing polymers with number-average MW equal to or greater than 10,000, and
- polymers containing as an integral part of their composition, except as impurities, certain perfluoroalkyl moieties consisting of a CF3- or longer chain length.
The manufacturer (which includes import) of any substance for which the polymer exemption is claimed under 40 CFR 723.250 must submit a report of manufacture (which includes import) by mail or courier to EPA by January 31 of the year subsequent to the year in which the substance was manufactured for the first time. This report should be submitted as follows:
US Postal Service:
U.S. Environmental Protection Agency (7407M)
WJC North Building
1200 Pennsylvania Ave, NW
Washington, DC 20460
Attn: Polymer Exemption
Hand Delivery or Courier:
WJC East Building, Room 6428
1201 Constitution Ave, NW
Washington, DC 20004-3302
Attn: Polymer Exemption